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CK-2017357 in Claudication
NCT01131013Phase 2
Key facts
- Status
- Completed
- Start
- May 2010
- Primary completion
- Mar 2011
- Countries
- 1
- Sponsor
- Cytokinetics
- Modality
- Small Molecules
- Drugs
- tirasemtiv
- Conditions
- intermittent claudication (IC)
01
Overview
Phase 2, randomised, double-blind trial of tirasemtiv in intermittent claudication (IC) (6 arms), sponsored by Cytokinetics. Primary endpoints: Time and work to onset of claudication during bilateral heel raises at 1 day, Time and work to intolerable claudication pain or maximal calf muscle fatigue at 1 day and 1 more. Started May 2010; status: completed.
02
Design
6 arms- Study design
- RandomizedDouble-blind
Sequence 1
Placebo -> 375 mg -> 500 mg
Sequence 2
Placebo -> 500 mg -> 375 mg
Sequence 3
375 mg -> Placebo -> 500 mg
Sequence 4
375 mg -> 500 mg -> Placebo
Sequence 5
500 mg -> Placebo -> 375 mg
Sequence 6
500 mg -> 375 mg -> Placebo
03
Who it enrols
Patients >40 years with stable intermittent claudication (Fontaine Stage II) and PAD (ABI <= 0.90). Excludes critical leg ischemia, poorly controlled hypertension/diabetes, and significant renal/hepatic insufficiency.
04
Endpoints
Primary
Time and work to onset of claudication during bilateral heel raises
Time and work to intolerable claudication pain or maximal calf muscle fatigue
Six-Minute Walk Test
Secondary
Relationship between plasma concentrations and functional measures
Number of patients with adverse events
05
Results
Not all primary endpoints met
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